TVMR With the INNOVALVE System Trial - Early Feasibility Study
Purpose
Study to evaluate the safety and performance of the INNOVALVE system
Condition
- Mitral Valve Regurgitation (Degenerative or Functional)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Clinically significant, symptomatic mitral regurgitation - High risk for open-heart surgery - Meets anatomical criteria
Exclusion Criteria
- Unsuitable anatomy - Patient is inoperable - EF<25%
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Treatment |
MV replacement with INNOVALVE system |
|
Recruiting Locations
Cedars-Sinai
Los Angeles 5368361, California 5332921 90048
Los Angeles 5368361, California 5332921 90048
Naples Comprehensive Health
Naples 4165565, Florida 4155751 34102
Naples 4165565, Florida 4155751 34102
Piedmont Heart Institute
Atlanta 4180439, Georgia 4197000 30309
Atlanta 4180439, Georgia 4197000 30309
Northwestern
Chicago 4887398, Illinois 4896861 60611
Chicago 4887398, Illinois 4896861 60611
University of Michigan Hospital and Health Systems
Ann Arbor 4984247, Michigan 5001836 48109
Ann Arbor 4984247, Michigan 5001836 48109
Mayo Clinic
Rochester 5043473, Minnesota 5037779 555905
Rochester 5043473, Minnesota 5037779 555905
Morristown Medical Center
Morristown 5101427, New Jersey 5101760 07960
Morristown 5101427, New Jersey 5101760 07960
Northwell Health
Manhasset 5125766, New York 5128638 11030
Manhasset 5125766, New York 5128638 11030
NewYork-Presbyterian / Columbia University
New York 5128581, New York 5128638 10032
New York 5128581, New York 5128638 10032
Cleveland Clinic
Cleveland 5150529, Ohio 5165418 44195
Cleveland 5150529, Ohio 5165418 44195
OhioHealth Research Institute
Columbus 4509177, Ohio 5165418 43214
Columbus 4509177, Ohio 5165418 43214
Oregon Health & Science Universtiy
Portland 5746545, Oregon 5744337 97239
Portland 5746545, Oregon 5744337 97239
University of Pennsylvania
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37203
Nashville 4644585, Tennessee 4662168 37203
Ascension Saint Thomas
Nashville 4644585, Tennessee 4662168 37205
Nashville 4644585, Tennessee 4662168 37205
Swedish Medical Center
Seattle 5809844, Washington 5815135 98122
Seattle 5809844, Washington 5815135 98122
More Details
- NCT ID
- NCT04919980
- Status
- Recruiting
- Sponsor
- Edwards Lifesciences
Detailed Description
The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the INNOVALVE system